Phase 2
N=14
Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant
Kidney Failure, Chronic · Diabetic Nephropathies · Glomerulonephritis, IGA · Hypertension, Renal
Bottom Line
View on ClinicalTrials.gov: NCT00446251 ↗Enrolled (actual)
14
Serious AEs
7.1%
Results posted
Mar 2010
Primary outcome: Primary: The Number of Subjects Who Experience a Decrease in Their Panel of Reactive Antibodies (PRA) at 6 Months Post Rituximab Infusion. — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab (Drug); Mycophenolate mofetil (MMF) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Subjects Who Experience a Decrease in Their Panel of Reactive Antibodies (PRA) at 6 Months Post Rituximab Infusion. |
6 | — |
| SECONDARY The Number of Subjects Who Experience a Change From Baseline in Their Panel of Reactive Antibody (PRA) Titers at 12 Months Post Rituximab Infusion. |
6 | — |
| SECONDARY The Number of Subjects With a Negative Crossmatch at the Time of Transplant. |
— | — |
Summary
This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment and at 6 and 12 months on combined therapy as well as the rates of transplant will be compared and evaluated using descriptive analysis.
Eligibility Criteria
Inclusion Criteria
- Age range 18 - 75, inclusive
- Able and willing to give written informed consent and comply with the requirements of the study protocol
- Outpatient status
- Patients with a Panel of Reactive Antibodies (PRA) over 10% after an 8-month trial of MMF monotherapy
- Patients with updated immunizations for tetanus, influenza, hepatitis B, pneumococcus
- Patients with a negative purified protein derivative(PPD ) screen for tuberculosis (TB)within the last 6 months. If subject has a prior history of TB or positive PPD, documentation of adequate treatment is required.
- Women who are of childbearing potential must have a negative serum pregnancy test prior to being enrolled in the study and agree to use a medically acceptable method of contraception throughout the study and for twelve months (1 year) after completion of treatment.
- Men must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
- Liver enzymes ALT and AST less than 2 times the normal limit.
Exclusion Criteria
- Active infection
- Receipt of live vaccine within 4 weeks prior to first infusion.
- Previous treatment with rituximab (MabThera® / Rituxan®)
- History of multiple recurrent infections defined as more than 3 urinary tract infections, 2 episodes of pneumonia or 3 episodes of otitis/sinusitis in one year, or more than two dialysis line or peritoneal infections within one year.
- Infection with hepatitis C virus (HCV) or hepatitis B virus(HBV) or human immunodeficiency virus (HIV), lack of documentation of treatment of a positive PPD, pregnant or breast-feeding, baseline leukopenia, white blood cell count (WBC) less than 4.0, thrombocytopenia (platelet count less than 100,000/mm) or difficult to treat anemia, a hematocrit chronically less than 32 on intravenous iron and EPO (erythropoietin) therapy, history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of psychiatric disorder
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
Data sourced from ClinicalTrials.gov (NCT00446251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.